In August 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a variant that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. Capmatinib was granted accelerated approval for the same indication in May 2020; the regular approval in August 2022 was based on additional data from 63 patients and follow-up data establishing durability of response and clinical benefit.
MET tyrosine kinase inhibitor
Mechanism of Action
Capmatinib inhibits the proto-oncogene c-MET by selectively binding to it, inhibiting phosphorylation, and disrupting signal transduction pathways. This can lead to apoptosis in cells that overexpress c-MET.
Adult patients with metastatic NSCLC whose tumors have a variant that leads to MET exon 14 skipping, as detected by an FDA-approved test
400 mg twice daily
Orally, with or without food
More than 20% of patients in capmatinib’s clinical trials reported experiencing edema, nausea, vomiting, musculoskeletal pain, fatigue, dyspnea, cough, and decreased appetite.
The package insert contains warnings for interstitial lung disease/pneumonitis, hepatotoxicity, pancreatic toxicity, hypersensitivity reactions, photosensitivity, and embryo-fetal toxicity.
Verify pregnancy status prior to initiating therapy. Monitor for new or worsening lung symptoms (e.g., dyspnea, cough). Monitor liver function tests prior to starting treatment, every two weeks during the first three months of treatment, and then once a month or as clinically indicated. Monitor amylase and lipase levels at baseline and at regular intervals during treatment.
Patients of reproductive potential should use effective birth control during treatment and for one week after the final dose. Breastfeeding is not advised during treatment and for one week after the final dose. Store mediation at room temperature in a safe place away from children and pets. Capmatinib can cause photosensitivity; patients should avoid ultraviolet exposure including tanning beds, use sunscreen, and wear protective clothing while on treatment. Download a handout to use for patient education.
Capmatinib can cause reproductive and organ toxicity; follow safe handling and disposal precautions.
Call 800-282-7630 or visit HCP.Novartis.com/Access.